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BioSig Announces Submission of FDA 510(k) Application for PURE EP™ System
Mar. 28, 2018 08:47AM PST
Biotech InvestingBioSig Technologies (OTCQB:BSGM) announced that the Company has filed 510(k) application to the U.S. Food and Drug Administration (FDA) for its first product, PURE EP™ System. As quoted in the press release: PURE EP System is a surface electrocardiogram and intracardiac multichannel recording system that acquires, processes and displays high fidelity cardiac recordings required during electrophysiology …
BioSig Technologies (OTCQB:BSGM) announced that the Company has filed 510(k) application to the U.S. Food and Drug Administration (FDA) for its first product, PURE EP™ System.
As quoted in the press release:
PURE EP System is a surface electrocardiogram and intracardiac multichannel recording system that acquires, processes and displays high fidelity cardiac recordings required during electrophysiology studies and catheter ablation procedures. The non-invasive PURE EP System is categorized as a Class II medical device according to the FDA and is subject to 510(k) performance standards and regulatory controls. The PURE EP System aims to minimize noise and artifacts and acquire high fidelity cardiac signals, which will potentially increase these signals’ diagnostic value, and offer improved accuracy and efficiency of the EP studies and related procedures.